FDA applicant
Shu Tong Xinghua Co., Ltd.
FDA records 2 decisions for Shu Tong Xinghua Co., Ltd. (Xinghua, CN) in 2014: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shu Tong Xinghua Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2014
2014high 2 (2014) · low 0 (2015)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Shu Tong Xinghua Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report